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CTRI Number  CTRI/2025/04/084564 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 10/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study on the Effectiveness of Zandu Rhumasyl Maxx Ayurvedic Liniment for Joint and Muscle Pain Relief 
Scientific Title of Study   An Open Label, Single Arm Observational Study to Assess the Efficacy of Zandu Rhumasyl Maxx - A Topical Ayurvedic Liniment in Adult Subjects for The Management of Pain & Inflammation Associated with Musculoskeletal Joint & Muscles 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PLC011125EL Version V01R1 Date 07.01.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Navin Balasubramanian 
Designation  Professor & HOD Department of Orthopaedics 
Affiliation  Saveetha Medical College and Hospital SIMATS 
Address  Department of Orthopaedics, 6th Floor, Hospital bulding clinical research facility room 01, Saveetha Medical College and Hospital SIMATS Thandalam Chennai India

Chennai
TAMIL NADU
602105
India 
Phone  09710929393  
Fax    
Email  drnavin_ortho@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Navin Balasubramanian 
Designation  Professor & HOD Department of Orthopaedics 
Affiliation  Saveetha Medical College and Hospital SIMATS 
Address  Department of Orthopaedics, 6th Floor, Hospital bulding clinical research facility room 01, Saveetha Medical College and Hospital SIMATS Thandalam Chennai India

Chennai
TAMIL NADU
602105
India 
Phone  09710929393  
Fax    
Email  drnavin_ortho@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Yogendra Kumar Choudhary 
Designation  Director & CEO 
Affiliation  Prothix Lifesciences Pvt Ltd 
Address  Prothix Lifesciences Pvt Ltd 2nd Floor Regus B-Block Shriram Business Park Vidhan Sabha Road Mowa

Raipur
CHHATTISGARH
492001
India 
Phone  09039340075  
Fax    
Email  ceo@prothixlifesciences.com  
 
Source of Monetary or Material Support  
Emami Ltd Emami Tower 687 Anandapur E.M. Bypass Kolkata 700107 India  
 
Primary Sponsor  
Name  Emami Ltd 
Address  Emami Ltd Emami Tower 687 Anandapur E.M. Bypass Kolkata 700107 India  
Type of Sponsor  Other [FMCG-Personal Care & Healthcare Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navin Balasubramanian  Saveetha Medical College and Hospital SIMATS  Department of Orthopaedics, 6th Floor, Hospital bulding clinical research facility room 01, Saveetha Medical College and Hospital SIMATS Thandalam Chennai India
Chennai
TAMIL NADU 		 09710929393

drnavin_ortho@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M190||Primary osteoarthritis of other joints. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Zandu Rhumasyl Maxx , Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult subject, Male or female between 18-65 years of age.
2. A score of 5cm or above on the NRS (at rest)
3. Subjects having Acute Musculoskeletal Pain e.g. musculoskeletal injuries (pain & inflammation), muscle cramps & symptoms associated with conditions such as osteoarthritis, sport injury, sprain, back pain, leg cramps, sciatica, frozen shoulder and spondylitis, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 sprain or strain), not requiring admittance to hospital.
4. Willing to give voluntary informed consent.
 
 
ExclusionCriteria 
Details  1. Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management. painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. Subjects with Grade 2 & 3 sprain or strain.
2. Subjects with known history of rheumatoid arthritis.
3. Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
4. Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action.
5. Subjects underlying dermatitis or dermatosis associated with the injury.
6. Use of any oral or topical analgesic, antipyretic, sedative, anti-inflammatory, muscle relaxants or any other oral or topical medications which in the opinion of the investigator would influence the conduct and outcomes of the study.
7. Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation.
8. Any kind of neuralgic pain, headache and/or chronic pain
9. Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
10. A known pregnancy or lactation
11. Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding.
12. Subjects who are severe smokers and drinkers
13. Received an investigational or product or participated in an investigational study within a period of 30 days prior to receiving study medication.
14. Scheduled elective surgery or other invasive procedures during the period of study participation.
15. Subjects with a history of diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases an active infectious disease (HBV, HCV, HIV) which in the opinion of the investigator would influence the conduct and outcomes of the study.
16. A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. NRS (at rest) SPID6 (Sum of Pain intensity difference)  [ Time Frame: day 1, day 7 and day 15] 
 
Secondary Outcome  
Outcome  TimePoints 
1. Earliest onset of analgesia
2. NRS (on movement) SPID6 (Sum of Pain intensity difference)
3. NRS (on pressure) SPID6 (Sum of Pain intensity difference)
4. PRS (at rest) TOTPAR6 (Total Pain Relief)
5. PRS (on movement) TOTPAR6 (Total Pain Relief)
6. PRS (on pressure) TOTPAR6 (Total Pain Relief)
7. McGill Short Form Questionnaire  		 [ Time Frame: day 1, day 7 and day 15] 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The potential participants who are willing to provide a written informed consent form will be asked to come for screening. The main inclusion criteria of the screening procedure will be an NRS score (at rest) of 4 or above. Onset of Analgesia, PRS & McGill –SFQ will also be taken at the screening which will be considered as the baseline score. The subjects will be asked specific history of pain like date of occurence, time of onset, duration of pain, part of the body affected, history of similar pain in the past (<24h, 24-48h, >48h), its severity, duration of pain, any treatment taken etc. Any underlying condition which will affect the current pain or evaluation of treatment will be sought for and excluded by history and physical examination. The participants will then be allocated to receive topical treatment of (IP) Zandu Rhumasyl Maxx for 15 days and on the day of scheduled visits (day1, day 7 and day 15) post dose for every 30 minutes’ interval up to 6hrs the participant will be asked to indicate their resting pain intensity, onset of analgesia, pain relief, and also their pain on movement using the NRS and PRS scale.  The investigator will also measure the pain on application of pressure using the NRS. McGill-SF questionnaire will be taken at all interventional visits and at the end of the study to evaluate quality of pain. A subject will remain on study until 15 days. Subjects who discontinue (IP) Zandu Rhumasyl Maxx before week 2 will be followed for 7 days after the last dose of (IP) Zandu Rhumasyl Maxx and then complete the end-of-study visit. The clinical site team will evaluate the safety data throughout the study, including an initial safety review after the first 15 subjects have received at least 1 application of (IP) Zandu Rhumasyl Maxx.  
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